MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM) 6118127110 manufactured by Stryker Instruments-kalamazoo.
[177390104]
A follow up report will be filed once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[177390105]
It was reported that there was a pin hole in the packaging. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188148847]
The reported product involved with this event was returned for evaluation and the reported failure of product packaging compromised was confirmed. The product was evaluated by the product packaging engineer who concluded that it is likely that this damage occurred during the distribution (including handling) or storage of the product. The handling may have been more aggressive than expected or an unexpected event occurred. The device has been packaged correctly in its qualified configuration.
Patient Sequence No: 1, Text Type: N, H10
[188148848]
It was reported that there was a pin hole in the packaging. It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2020-00368 |
| MDR Report Key | 9653981 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. UNA BARRY |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal | NA |
| Manufacturer Phone | 214532900 |
| Manufacturer G1 | STRYKER INSTRUMENTS-IRELAND |
| Manufacturer Street | INSTRUMENTS DIVISION CARRIGTWOHILL BUS. & TECH PARK |
| Manufacturer City | CARRIGTWOHILL NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFORMANCE SERIES SAGITTAL BLADE (18.0X1.27X110.0MM) |
| Generic Name | BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL |
| Product Code | GFA |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-01-13 |
| Model Number | 6118127110 |
| Catalog Number | 6118127110 |
| Lot Number | 19064017 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |